Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction

NCT ID: NCT01063855

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 495 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-09-30

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of dapoxetine compared to placebo in men with premature ejaculation and erectile dysfunction who are currently being treated with a phosphodiesterase-5 inhibitor (ie, sildenafil, vardenafil, or tadalafil) for erectile dysfunction.

Detailed Description

Premature ejaculation (PE) and erectile dysfunction (ED) are forms of sexual dysfunction in men. An objective measurement of PE in clinical studies is the intravaginal ejaculatory latency time (IELT), which is the time it takes for a man to ejaculate during sexual intercourse (as measured by stopwatch). This is a multicenter, double-blind (neither the physician or the study participant will know the identity of the treatment assigned), randomized (study drug assigned by chance) efficacy and safety study of dapoxetine compared with placebo (a sugar pill) in men with premature ejaculation who are currently being treated for ED with a phosphodiesterase 5 (PDE-5) inhibitor such as sildenafil, vardenafil, or tadalafil. A maximum of 656 men 18 years or older (hereafter referred to as study participants) who have received treatment with a PDE-5 inhibitor for at least 3 months prior to study entry will be enrolled. The study will last approximately 18 weeks and includes a 4-week screening period, a 12-week treatment period, and a follow-up telephone contact approximately 2 weeks after the end of treatment. Both the study participant and his partner will be required to attend the screening visit and to sign an informed consent form documenting that they understand and agree to the requirements for the study. After initial screening procedures are completed, study participants who qualify for the study will enter a 4-week screening period. During the 4 weeks, the study participant and his partner will be provided with a stopwatch to time and record the IELT during all attempts at sexual intercourse. At the next scheduled clinic visit which is Day 1 of the double-blind treatment period, study participants who continue to qualify for the study will be assigned by chance (like flipping a coin) to receive 1 of 2 study treatments (dapoxetine or placebo) for 12 weeks in addition to prescribed treatment with a PDE-5 inhibitor. Study participants will be instructed to take study drug with or without food with at least 1 full glass of water approximately 1 to 3 hours before sexual activity (no more than 1 dose should be taken within a 24-hour period). During the 12-week treatment period, the study participant and his partner will be asked to time and record the IELT during all attempts at sexual intercourse on Treatment Event Logs provided. Study participants will return to the clinic after 4, 8 and 12 weeks of treatment for routine safety assessments (including review of Treatment Event Logs returned) and to be dispensed study drug. Following 12 weeks of treatment (or at the time of early withdrawal from the study) end-of-treatment safety and efficacy evaluations will be performed at the final clinic visit. Approximately 2 weeks later, a follow up telephone call will be made to the study participant to collect information on any adverse events that may have occurred or concomitant therapy received since the time of the last clinic visit. The primary outcome measure in the study is the average IELT, as measured by stopwatch, during sexual intercourse at the end of the treatment period (Week 12). Safety will be monitored during the study by evaluating adverse events, physical examination findings, results from clinical laboratory tests, and concomitant medication usage. An Independent Data Monitoring Committee (IDMC) will be established to monitor the safety and efficacy of study participants during the study. In addition, an interim (preliminary) analysis will be performed during the study to monitor safety and efficacy after approximately 268 men have completed 12 weeks of treatment (also includes any study participants who did not complete treatment and were withdrawn early from the study). Study participants will receive either dapoxetine or matching placebo tablets at a dose of 30 mg prn (as needed) taken orally (by mouth) with or without food with at least 1 full glass of water approximately 1 to 3 hours before sexual activity (not to be taken more than once every 24 hours). At Weeks 4 or 8, the dose of dapoxetine or matching placebo may be increased to a maximum of 60 mg prn if specific predefined criteria are met or be subsequently decreased from 60 to 30 mg at Weeks 4 or 8.

Conditions

Erectile Dysfunction; Sexual Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dapoxetine + PDE5I

Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + a PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.

Group Type: EXPERIMENTAL

Dapoxetine

Intervention Type: DRUG

30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks.

PDE5I (phosphodiesterase-5 inhibitor)

Intervention Type: DRUG

Patients were to be using a stable regimen of a PDE5-I (i.e., sildenafil, vardenafil, or tadalafil), as reported by the patient for the treatment of erectile dysfunction (ED) for at least 3 months before screening and up to 12 weeks during treatment in the study.

Placebo + PDE5I

Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + a PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks.

PDE5I (phosphodiesterase-5 inhibitor)

Intervention Type: DRUG

Patients were to be using a stable regimen of a PDE5-I (i.e., sildenafil, vardenafil, or tadalafil), as reported by the patient for the treatment of erectile dysfunction (ED) for at least 3 months before screening and up to 12 weeks during treatment in the study.

Interventions

Placebo

Tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks.

Intervention Type: DRUG

Dapoxetine

30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks.

Intervention Type: DRUG

PDE5I (phosphodiesterase-5 inhibitor)

Patients were to be using a stable regimen of a PDE5-I (i.e., sildenafil, vardenafil, or tadalafil), as reported by the patient for the treatment of erectile dysfunction (ED) for at least 3 months before screening and up to 12 weeks during treatment in the study.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of erectile dysfunction (ED), International Index of Erectile Function (IIEF) score >=21 at screening and baseline, and receiving treatment with a stable regimen of a phosphodiesterase 5 (PDE 5) inhibitor (ie, sildenafil, vardenafil, or tadalafil) for the treatment of ED for at least 3 months before screening
• Study participant in a stable, monogamous sexual relationship with the same woman for at least 6 months before screening and plan to maintain this relationship for the duration of the study
• Study participant medically stable (ie, in good general health) on the basis of physical examination, medical history, vital signs, 12 lead ECG, and clinical laboratory tests performed at screening

Exclusion Criteria

• History suggestive of syncope (a condition characterized by a loss of consciousness)
• History of medical events such as surgical interventions or neurologic conditions (eg, multiple sclerosis), trauma, or infections that are associated with the development of symptoms of premature ejaculation (PE) and considered a potential cause of PE
• Current major psychiatric disorder such as mood disorder, anxiety disorder, schizophrenia, mania, suicidal ideation, other psychotic disorder, or alcoholism
• Known allergy, hypersensitivity, or intolerance to selective serotonin reuptake inhibitors (SSRIs) or selective noradrenaline reuptake inhibitors (SNRIs)
• Taken another investigational drug (or vaccine) within 30 days or used an investigational medical device within 6 months before screening, or enrolled in another investigational study

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Decatur, Alabama, United States

Huntsville, Alabama, United States

Englewood, Colorado, United States

Aventura, Florida, United States

Clearwater, Florida, United States

Gainesville, Florida, United States

West Palm Beach, Florida, United States

Evansville, Indiana, United States

Fort Wayne, Indiana, United States

Baltimore, Maryland, United States

Olive Branch, Mississippi, United States

Kansas City, Missouri, United States

Poughkeepsie, New York, United States

Raleigh, North Carolina, United States

Cleveland, Ohio, United States

Portland, Oregon, United States

Salem, Oregon, United States

Ettrick, Virginia, United States

Middleton, Wisconsin, United States

Buenos Aires, , Argentina

Ciudad Autonoma de, , Argentina

Malvern, , Australia

Maroubra, , Australia

Perth, , Australia

St Leonards, , Australia

Brussels, , Belgium

Edegem, , Belgium

Liège, , Belgium

Coquitlam, British Columbia, Canada

Guelph, Ontario, Canada

Newmarket, Ontario, Canada

Oakville, Ontario, Canada

Sarnia, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Pointe-Claire, Quebec, Canada

Garches, , France

Lille, , France

Lyon, , France

Marseille, , France

Nîmes, , France

Paris, , France

Toulouse, , France

Kuala Lumpur, , Malaysia

Kuching, , Malaysia

Petaling Jaya, , Malaysia

Cd. de Mexico, , Mexico

Culiacán, , Mexico

Durango, , Mexico

Monterrey, , Mexico

Katowice, , Poland

Lodz, , Poland

Lublin, , Poland

Szcezecin, , Poland

Wroclaw, , Poland

Moscow, , Russia

Saint Peterburg, , Russia

Saint Petersburg, , Russia

Chunjoo, , South Korea

Kwangjoo, , South Korea

Pusan, , South Korea

Seoul, , South Korea

Kaohsiung City, , Taiwan

Taoyuan District, , Taiwan

Chipping Norton, , United Kingdom

Leeds Yorkshire, , United Kingdom

Lichfield, , United Kingdom

Reading, , United Kingdom

South Brent, , United Kingdom

Countries

United States; Argentina; Australia; Belgium; Canada; France; Malaysia; Mexico; Poland; Russia; South Korea; Taiwan; United Kingdom

References

McMahon CG, Giuliano F, Dean J, Hellstrom WJ, Bull S, Tesfaye F, Sharma O, Rivas DA, Aquilina JW. Efficacy and safety of dapoxetine in men with premature ejaculation and concomitant erectile dysfunction treated with a phosphodiesterase type 5 inhibitor: randomized, placebo-controlled, phase III study. J Sex Med. 2013 Sep;10(9):2312-25. doi: 10.1111/jsm.12236. Epub 2013 Jul 11.

Reference Type: DERIVED

PMID: 23845016 (View on PubMed)

Other Identifiers

R096769PRE3008

Identifier Type: OTHER

Identifier Source: secondary_id

2009-013616-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR016486

Identifier Type: -

Identifier Source: org_study_id